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FDA 510(k)

RUBBER, DENTAL DAM (NON-STERILE)

K-Number: K901236 · 1990-06-06

ApplicantNaturub Sdn. Bhd.
Decision Date1990-06-06
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RUBBER, DENTAL DAM (NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Naturub Sdn. Bhd.. It received FDA 510(k) clearance on 1990-06-06 under 510(k) number K901236. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBBER, DENTAL DAM (NON-STERILE)?

RUBBER, DENTAL DAM (NON-STERILE) is a medical device that received FDA 510(k) clearance on 1990-06-06. The listed applicant is Naturub Sdn. Bhd.. The 510(k) number is K901236.

When did RUBBER, DENTAL DAM (NON-STERILE) receive FDA 510(k) clearance?

RUBBER, DENTAL DAM (NON-STERILE) received FDA 510(k) clearance on 1990-06-06, under 510(k) number K901236.

Who is the listed applicant for RUBBER, DENTAL DAM (NON-STERILE)?

The FDA 510(k) record lists Naturub Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBBER, DENTAL DAM (NON-STERILE)?

The FDA product code for RUBBER, DENTAL DAM (NON-STERILE) is EIE.

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Other records listing Naturub Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K892970PATIENT EXAMINATION GLOVES (LATEX)K893115LATEX EXAMINATION GLOVES

Related Devices (Code: EIE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182118armor LCMavrik Dental Systems, Ltd.K151945Triumph Resin DamDenali CorporationK050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.K043301GC TION GINGIVAL PROTECTORGC America, Inc.K040797BRITESMILE MASKING CREAMBritesmile, Inc.K022522PULPDENT PUTTY DAMPulpdent Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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